البلد: مالطا
اللغة: الإنجليزية
المصدر: Medicines Authority
PHYTOMENADIONE; DL-ALFA-TOCOPHEROL; ERGOCALCIFEROL; RETINOL
Fresenius Kabi Limited
B05BA10
PHYTOMENADIONE; DL-ALFA-TOCOPHEROL; ERGOCALCIFEROL; RETINOL
EMULSION FOR INFUSION
PHYTOMENADIONE 20 µg/ml; DL-ALFA-TOCOPHEROL 0.64 mg/ml; ERGOCALCIFEROL 1 µg/ml; RETINOL 69 µg/ml
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Authorised
2007-06-12
333 133 size: 210 x 148, 2:a kor r 09-09-11, Johanna Eriksson 2212112222 2212112222 333 133 P ACKAGE LEAFLET : INFORMA TION FOR THE USER V ITLIPID ® N INFANT CONCENTR ATE FOR EMULSION FOR INFUSION Read all of this leafl et carefully before your child starts taking this medicine. • Keep this leafl et. Y ou may need to r ead it again. • If you have any further questions, ask your doctor or phar macist. • This medicine has been pr escribed for your child. Do not pass it on to others. It may har m them, even if their symptoms ar e the same as yours. • If any of the side ef fects get serious, or if you notice any side ef fects not listed in this leafl et, please tell your doctor or phar macist. In this leafl et: 1. What is V itlipid ® N Infant and what it is used for 2. Befor e your child r eceives V itlipid ® N Infant 3. How your child will be given V itlipid ® N Infant 4. Possible side ef fects 5. How V itlipid ® N Infant is stor ed 6. Further infor mation 1. WHA T IS VITLIPID ® N INF ANT AND WHA T IT IS USED FOR V itlipid ® N Infant is especially designed for babies and childr en. It pr ovides fat soluble vitamins in your child’ s par enteral nutrition when your child cannot eat nor mally . It is usually used as part of a balanced intravenous diet, together with pr oteins, fat, carbohydrates, salts and other vitamins. 2. BEFORE YOUR CHILD RECEIVES VITLIPID ® N INF ANT Y our child should not receive V itlipid ® N Infant: • if he/she is aller gic (hypersensitive) to V itlipid ® N Infant or any of the ingr edients of V itlipid ® N Infant mentioned in Section 6. If you develop a rash or other aller gic r eactions (like itching, swollen lips or face or shortness of br eath), please infor m your doctor . • if he/she has ever suf fer ed an aller gic r eaction to egg, soya or peanut pr otein • if it is undiluted. It will be added to another solution known as Intralipid ® befor e it is given to اقرأ الوثيقة كاملة
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vitlipid N Infant 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: Retinol palmitate 69 micrograms corresponding to retinol (230 IU) Ergocalciferol 1 micrograms (40 IU) dl-alpha-tocopherol 0.64 mg (0.7 IU) Phytomenadione 20 micrograms 3. PHARMACEUTICAL FORM Concentrate for emulsion for infusion. White oil in water emulsion for infusion. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitlipid N Infant is indicated as a supplement to Intralipid 10% or 20% in the intravenous nutrition of infants and children (under 11 years of age) in order to cover the daily requirements of the fat soluble vitamins A 1 , D 2 , E and K 1 . 4.2 POSOLOGY AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE FOR INFANTS AND CHILDREN (UNDER 11 YEARS OF AGE) 4 ml/kg bw/day to pre-term and low birth weight infants up to 2.5 kg bodyweight. 10 ml/day for all infants and children weighing more than 2.5 kg up to 11 years. RECOMMENDED DOSAGE FOR CHILDREN (OVER 11 YEARS OF AGE), ADULTS AND THE ELDERLY It is recommended that the adult preparation Vitlipid N Adult (MA 134/00301) be used. Page 2 of 4 4.3 CONTRA-INDICATIONS Vitlipid N Infant should not be administered undiluted. Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE This medicinal product contains soya-bean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut. 4.5 IN اقرأ الوثيقة كاملة